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A Phase IIa Clinical Study of Purinostat Mesylate for Injection in Patients With Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record status
This record was last updated February 6, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Nov 22, 2025 to Jun 30, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 22, 2025 to Dec 31, 2026
    • Site details revised at 2 of 2 sites
    v3
  2. Start date: Nov 22, 2023 to Apr 14, 2024v2 Show 5 more changesShow less
    • Eligibility criteria shortened, about 79 words
    • Secondary endpoints: 4 to 6
    • Site contacts updated at 2 of 2 sites
    • Study arms: 1 to 2
    • Study title expanded, about 1 word
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Primary Objective To evaluate the preliminary efficacy of Purinostat Mesylate for Injection in patients with relapsed or refractory Peripheral T-Cell Lymphoma (PTCL) and Cutaneous T-Cell Lymphoma (CTCL). Secondary Objectives 1. To evaluate the safety and tolerability of Purinostat Mesylate for Injection in patients with relapsed or refractory PTCL and CTCL. 2. To evaluate the population pharmacokinetic characteristics of Purinostat Mesylate for Injection in patients with relapsed or refractory PTCL and CTCL. Exploratory Objective To investigate the relationship between tumor biomarkers and the therapeutic efficacy/safety profile of Purinostat Mesylate for Injection.
Trial Details
NCT Number NCT06485219
Lead Sponsor Chengdu Zenitar Biomedical Technology Co., Ltd
Conditions
(from sponsor)		 Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL)
Related terms Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Peripheral, Recurrence
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov